The purpose of this study is to determine the best strategy to manage Dabigatran at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of Dabigatran will result in a reduced rate of clinically significant hematoma.

A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Dabigatran at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the Incidence of Clinically Significant Hematoma

- Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome.

Discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min

Resume Dabigatran at next regular dose timing at least 24 hours after the end of surgery

Drug: Dabigatran

Other Names:

Pradax

Pradaxa

Detailed Description:

This is a prospective, open-label, randomized trial, with 1:1 randomization to either continued Dabigatran or interrupted Dabigatran in patients at moderate to high risk of arterial thrombo-embolic events who require device surgery.

All patients in the study will be treated with Dabigatran for at least 5 days prior to surgery. Regardless of the chronic dose, all patients will receive Dabigatran 110 mg BID for 5 days prior to device surgery and for the 5 days following surgery. The peri-operative management of Dabigatran 110 mg BID is randomized to the following:

Interrupted Dabigatran

based on renal function, patients will discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min, and 2 days before surgery if GFR is 30-50 mL/min.

Dabigatran will be resumed at the next regular dose time, at least 24 hours after the end of surgery.

Continued Dabigatran

patients will continue on Dabigatran 110 mg BID throughout

patients will have an aPTT measured at trough (within 2 hours prior to next dose)once within 5 days prior to the surgery. If the aPTT is > 2.5 times the upper limit of normal, the dose of Dabigatran will be held on the morning of surgery.

All patients will have clinical lab testing of serum creatinine, CBC, INR, aPTT, thrombin clotting time (TCT) and Hemoclot test on the day of surgery.

Patients will be seen post-op on the day of their surgery for assessment of the surgical site and each day throughout their hospital stay by a blinded member of the research team. A telephone follow-up will be done on day 3-4 post surgery by an unblinded team member. All patients are seen 1-2 weeks post-op at their first routine post-op device clinic visit, for surgical site assessment by the blinded assessor and to complete Quality of Life questionnaires. Patients will be seen for assessment in the case of any bleeding or development of pocket swelling or hematoma. Patients developing a hematoma will be followed until resolution of the hematoma.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675076